देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
NAOMI SHACO-EZRA LTD
N02AE01
TABLETS SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE 8.64 MG; NALOXONE HYDROCHLORIDE DIHYDRATE 2.44 MG
PER OS
Required
INDIVIOR UK LIMITED, UK
BUPRENORPHINE
BUPRENORPHINE
Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse.Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction
2018-03-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only Suboxone 2 mg/0.5 mg Sublingual tablets Suboxone 8 mg/2 mg Sublingual tablets Active ingredients: Buprenorphine (as hydrochloride) 2 mg Naloxone (as hydrochloride dihydrate) 0.5 mg Buprenorphine (as hydrochloride) 8 mg Naloxone (as hydrochloride dihydrate) 2 mg Inactive ingredients and allergens: see section 6 "Further Information" and in section 2 “Important information regarding some of the ingredients of the medicine” . Read this leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat your ailment. Do not pass it on to others . It may harm them even if it seems to you that their medical condition is similar. The medicine is intended for use in adults and adolescents over 15 years of age. 1. WHAT IS THE MEDICINE INTENDED FOR? Suboxone belongs to a group of medicines that act on the nervous system and are used to treat addiction disorders. Suboxone is used to treat dependence on opioid preparations (narcotics), such as heroin or morphine, in drug addicts who have agreed to be treated for their addiction. Suboxone is used in adults and adolescents over 15 years of age, who are also receiving medicinal, social and psychological support. Therapeutic group: Buprenorphine - semi-synthetic opioid. Naloxone - opioid agonist with antagonistic activity. 2. BEFORE USING THE MEDICINE 2.1 Do not use Suboxone if: you are sensitive (allergic) to buprenorphine, naloxone (the active ingredients in Suboxone) or to any of the other ingredients in the medicine. For the list of inactive ingredients, see section 6. you have serious breathing problems . you have serious problems with your liver . you suffer from intoxication due to alcohol consumption or if you suffer from trembling, swe पूरा दस्तावेज़ पढ़ें
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Suboxone 2 mg/0.5 mg sublingual tablets Suboxone 8 mg/2 mg sublingual tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Suboxone 2 mg/0.5 mg sublingual tablets Each sublingual tablet contains 2 mg buprenorphine (as hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate). Suboxone 8 mg/2 mg sublingual tablets Each sublingual tablet contains 8 mg buprenorphine (as hydrochloride) and 2 mg naloxone (as hydrochloride dihydrate). Excipients with known effect: Each Suboxone 2 mg/0.5 mg sublingual tablet contains 42 mg lactose (as monohydrate) Each Suboxone 8 mg/2 mg sublingual tablet contains 168 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sublingual tablet Suboxone 2 mg/0.5 mg sublingual tablets White hexagonal biconvex tablets of 6.5 mm with “N2” debossed on one side. Suboxone 8 mg/2 mg sublingual tablets White hexagonal biconvex tablets of 11 mm with “N8” debossed on one side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction. 4.2 Posology and method of administration Treatment must be under the supervision of a physician experienced in the management of opiate dependence/addiction. Posology Precautions to be taken before induction Baseline liver function tests and documentation of viral hepatitis status are recommended prior to commencing therapy. Patients who are positive for viral hepatitis, on concomitant medicinal products (see section 4.5) and/or have existing liver dysfunction are at risk of accelerated liver injury. Regular monitoring of liver function is recommended (see section 4.4). 2 Prior to treatment initiation, consideration should be given to the type पूरा दस्तावेज़ पढ़ें